Abstract
Topical monotherapy of nail infection is limited by poor drug permeability into the human nail plate. Numerous substances and methods are applied to improve the antifungal agent delivery across the nail plate. This work aimed to evaluate the effect of chemical and physical enhancers on the accumulation and permeation of amorolfine hydrochloride through human nail clippings. Polymeric nail lacquers with Eudragit E100 were developed as a potentially suitable delivery system for amorolfine hydrochloride. Incorporating thioglycolic acid and urea into formulations provided increased accumulation of antifungal agent in nail layers of up to 100% and 57%, respectively. Structural changes of nail barrier, induced by fractional CO2 laser, were visualized by microscopy. The permeation of amorolfine hydrochloride through the nail increased twofold when thioglycolic acid-containing formulation was applied and the nail was pretreated with a fractional CO2 laser. The results suggest that this novel combination of enhancers has the potential to be an effective option for topical drug delivery through the nail, and increased the efficacy of treatment.
Highlights
A human nail is composed of the nail plate and four epithelial tissues: nail matrix, hyponychium, nail bed, and perionychium [1]
The permeation of amorolfine hydrochloride through the nail increased twofold when thioglycolic acid-containing formulation was applied and the nail was pretreated with a fractional CO2 laser
Bovine hoof membranes have been used as a model for human nail plates, which are less in penetration available for suchobtained permeation studies
Summary
A human nail is composed of the nail plate (thin structure of approximately 25 layers of keratinocytes with keratin filaments matrix) and four epithelial tissues: nail matrix, hyponychium, nail bed, and perionychium [1]. Onychomycosis is a common nail disease which affects up to 14% of the population [2]. The current treatment of onychomycosis includes systemic therapies, topically applied products, and surgical interventions [3]. Systemic treatment of onychomycosis presents safety issues due to possible drug–drug interactions and hepatotoxicity [3,4]. Topical therapy of onychomycosis is advantageous due to its localized effect and that delivery of the drug to the infected nail is direct. Topical therapy offers decreased systemic side effects, the efficacy of such therapy depends on achieving effective concentrations of antifungal agents at the infection site [5,6]
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